Author(s): Comella P, Gambardella A, Farris A, Maiorino L, Natale D,
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Abstract From September 2001 to November 2002, 35 patients aged 70-81 (median, 75) years, with measurable metastatic lesions from colorectal carcinoma, were treated with a combination of oxaliplatin (OXA) infused i.v. over 2 h on day 1, and capecitabine, assumed orally twice a day (12-h apart) from day 2 to day 15. An alternated dose escalation for both drugs was planned over the first three cycles for each patient, in the absence of WHO grade > or =2 toxicity on previous cycle: starting doses were 85 mg/m2 for OXA, and 2000 mg/m2 (day) for capecitabine on first cycle; on second cycle, OXA was planned at 100mg/m2, while capecitabine was planned at 2500 mg/(m2 day) on third cycle. Treatment was repeated every 3 weeks until progression, or for a maximum of 12 cycles. A total of 212 cycles were administered, with a median of 6 (range, 1-12) cycles/patient. Dose escalation was performed in 18 (51\%) patients for OXA, and in 4 (11\%) patients for capecitabine. No grade 4, and 10 (29\%) cases of grade 3 toxicity of any type were reported. Abdominal symptoms (pain, nausea, or vomiting) affected 66\% of patients, but they were of grade 3 in only 2 (6\%) patients. Grade 3 diarrhoea occurred in 3 (9\%) patients. Two complete and 12 partial responses (PR) were reported, for an overall response rate of 40\% (95\% CI, 24-58\%). Progression of disease occurred in 23 (66\%) patients, and 18 (51\%) died. The actuarial median progression-free and survival time were 6.9 and 14.1 months, respectively.
This article was published in Crit Rev Oncol Hematol
and referenced in Biology and Medicine